Elastomeric gloves and methods of making

ABSTRACT

Elastomeric film-like products such as natural latex gloves are coated with novel lubricity compositions and compositions which protect the skin of the wearer from certain undesirable medical conditions. In powder-coated gloves, the coating composition comprises rice starch, and optionally USP-grade colloidal oatmeal in pharmaceutically accepted concentration. In powder-free gloves, the coating composition comprises colloidal oatmeal enhanced water or beta glucan solution, optionally in combination with one or more other starch components. Colloidal oatmeal enhanced water, and methods of making the colloidal oatmeal enhanced water are also disclosed. In addition, beta glucan solution, and methods of making the beta glucan solution are also disclosed. A liquid referred to herein as Polycoat may also be made by mixing colloidal oatmeal enhanced water with beta glucan solution, and the resulting liquid may be applied to elastomeric articles such as gloves.

RELATED APPLICATION

This patent application claims priority on a provisional patentapplication of the same title, Ser. No. 60/715,339 filed Sep. 7, 2005,which is incorporated herein by reference.

BACKGROUND

1. Technical Field

This disclosure generally relates to methods for making elastomericgloves, and more specifically relates to methods for making elastomericgloves that include one or more coatings derived from oats.

2. Background Art

As is known in the art, flexible impermeable elastomer-based glovesinclude both disposable gloves and reusable gloves. The aforementionedgloves (as well as certain other flexible elastomeric articles which areused adjacent the skin or other membrane of a user's body are thin,flexible, and fluid impermeable. The substrate body of the glove cangenerally be formed from any of a wide variety of natural rubbers and/orsynthetic elastomeric materials known in the art. For instance, someexamples, without limitation, of suitable materials useful in making theglove substrate body include, but are not limited to, certain materialscharacterized as SEBS (styrene-ethylene-butylene-styrene) blockcopolymers, SI (styrene-isoprene) block copolymers, SIS(styrene-isoprene-styrene) block copolymers, SBS(styrene-butadiene-styrene) block copolymers, SB (styrene-butadiene)block copolymers, natural rubber latex, nitrile rubbers, isoprenerubbers, chloroprene rubbers, polyvinyl chlorides, silicone rubbers,elastomeric polyurethanes, neoprene, butadiene methylmethacrylates,acrylonitriles, acrylate-based hydrogels, and combinations thereof.Other suitable elastomeric materials can also be used to form thesubstrate body of the glove. Those skilled in the art are well aware ofthe various materials from which such gloves can be made.

The glove substrate body is generally considered to be that structurewhich provides the primary structural strength to the glove. The glovesubstrate can be fabricated with a single layer of substrate material,or multiple layers of substrate material. In gloves which have multiplesubstrate layers, all the layers can be defined by a common substratematerial composition, or one or more of the layers can be defined bysecond and optionally additional different substrate materialcompositions.

In fabricating a glove, typically, the elastomer composition from whichgloves are to be formed is expressed in a liquid form. For example, theelastomer can be suspended in an emulsion. Glove molds, for exampleceramic molds, are dipped into the emulsion, thereby coating materialfrom the emulsion onto the molds. The molds can be removed from theemulsion, the liquid carrier can be flashed off from the molds, and thelatex can be cured and/or vulcanized or otherwise treated, thereby toleave the glove substrate material coated onto the respective molds. Theglove substrates can be coated with a donning agent, then stripped fromthe molds and inverted. The glove substrates are typically inverted inthe process of being stripped from the molds. In the alternative, theglove substrates can be first stripped from the mold without having beencoated with a donning agent, and subsequently coated with any desireddonning agent.

A typical glove has a non-wearer-contacting surface, generally referredto as an “outer surface”, or an “outside surface”. The glove also has anopposite, wearer-contacting surface.

The materials commonly used to form glove substrates and substratelayers, for example natural latex rubber, tend to be sticky or tacky,which makes it difficult to don the glove, namely to put the glove onthe user's hand. The commonly-used substrate materials also tend to trapperspiration from the user's hand inside the glove.

Disposable gloves are widely used by members of the medical community,the scientific community, and the industrial community to protect thewearer from chemical exposure, mechanical abrasion, environmentalhazards, and biohazard contamination, and to prevent transmission ofdisease or contaminants. Health care providers commonly wear gloves fora single use while performing surgery or other medical or dentalprocedures such as patient examinations. Thus, the gloves which are thesubject of this disclosure are often referred to as disposableexamination gloves or disposable surgical gloves, and in general asdisposable gloves.

The glove substrates of gloves discussed herein are designed to begenerally impermeable to biological fluids, tissues, and solids whichare produced by the body, as well as being generally impermeable toother contaminants (human or animal), thus advantageously protecting thewearer from fomitic transmission (transmission by objects that harborpathogenic organisms) of pathogens and diseases.

Gloves are also worn by individuals who wish to protect their hands fromvarious chemicals, materials, and objects which may irritate, damage,dry out, or otherwise negatively affect the user's skin, and which maybe harmful or potentially harmful if allowed to contact or permeate thedermal barrier. Scientists, cleaning service workers, food processingworkers, food handlers, law enforcement workers, beauticians or otherworkers having special protection needs, wear such gloves in theoccupational environment. Thus, gloves discussed herein can also includeprotective gloves or industrial gloves. Also, some gloves, for examplehousehold gloves or gardening gloves, are made with more durablesubstrates, for example thicker substrates, whereby the gloves areconsidered reusable gloves because they can be used multiple times priorto disposal, and the anticipated uses carry lower risk of deleteriouslycontaminating the user from outside sources, or of deleteriouslycontaminating a person being serviced by the user.

In a medical or other intimate use environment, flexible elastomerarticles, such as disposable gloves, are frequently changed by thewearer during the day between patients or between procedures or otheractivities. Allergy and irritation potential of a finished disposableglove has been exacerbated by common glove manufacturing practices ofusing vulcanizing accelerators, antioxidants, certain powders and otheradditives as a means to speed production of the glove substrate, to easedonning of the glove, to prevent or cover tackiness, to enhancedurability during storage and use life of the glove, and the like. Inaddition, when conventional disposable gloves cover the hand, moisture(perspiration) is trapped between the skin of the hand and the innersurface of the glove, contributing to hand dermatitis, and potentiallyother skin problems. Some healthcare providers assertedly struggle withallergic or irritant contact dermatitis or IgE mediated latexhypersensitivity (Type I) whereby such individuals carry an artificiallyheightened susceptibility to skin disease or infection.

In attempting to address such skin-care issues, some glove users applylotions, creams, and/or other emollients in attempts to moisturize theirhands. Such emollients frequently are oil-based which can deleteriouslyaffect a natural latex rubber glove. Further, such emollients sometimescontain certain antigenic chemicals which serve to exacerbate theabove-mentioned and/or other skin problems.

The art has responded to the tackiness and donning problems ofelastomer-substrate gloves in a number of ways. One solution which hasbeen suggested for addressing the aforementioned donning problems is totreat the glove with a powder, such as cornstarch, oat starch, talcum(talc) powder, other starch dusting powders, polyglycolic acid powder,insoluble sodium metaphosphate powder, magnesium carbonate, or granularvinyl chloride polymer. Some such powders are used in combination withother powders or with other ingredients. Most elastomers from which theglove substrate is made are inherently sticky on their surfaces, causinga blocking effect, which makes it difficult to don the glove, put theglove on, without the assistance of a donning agent. Commonly, across-linked cornstarch powder is used inside the glove, as a donningagent, to facilitate donning the glove.

The aforementioned powders can provide apparent comfort to the wearer'shand as the hand moisture builds up within the glove as the glove isused, but conversely can also act to dry, to abrade and/or to otherwiseirritate the user's skin.

The substrate materials most commonly used in fabricating glovesubstrates which are used to make gloves are natural latex rubbers. Itis known that natural latex rubber antigenic proteins migrate to thesurface of a disposable natural latex rubber glove substrate, or otherflexible article, and are known to have a propensity toelectrochemically bind to the cross-linked cornstarch powder particleswhich are typically used as a donning coating on such natural latexrubber gloves.

The cornstarch particles serve as vehicles to carry the antigenproteins. Such carrying of the proteins has been shown to be problematicto a fraction of the users of such gloves, in that a certain amount ofthe powder may be aerosolized from the glove during normal use anddisposal of the glove. Such aerosolized powder particles can be inhaledby the wearer of the glove, or other person in the vicinity, duringnormal breathing, whence such powder is delivered to the immunoactivetissue of the nasopharynx and the bronchial tree, where the respectiveproteins may be harmful. This delivery and corresponding bodily responsemechanism occurs because macrophages and specialized T cells and B cellswhich are concentrated in the tissue of the nasopharynx and bronchialtree become sensitized and produce IgE specific antibodies, whichrecognize the natural latex rubber antigens, carried by the cornstarch.Thus, cornstarch powder used in natural latex rubber gloves can causesystemic natural latex rubber allergies and skin irritation, and canexacerbate contact allergies.

Another problem with the use of certain powders, such as talc andcornstarch, in surgical gloves is the concern about adhesion formationin a patient's surgical site. This is a particularly significant problemas an intraperitoneal postoperative complication where adhesions of thebowel cause significant sequellae in some patients. As a partialresponse to this issue, surgeons are provided with towels after donningsurgical gloves, for use to wipe off as much of the powder as possible.However, such procedure is not completely successful whereby a certainamount of powder remains on the gloves after such wiping action. Theremaining powder particles are known to be responsible for irritationwhich allegedly can produce scarring in the surgical site, whichscarring can be responsible for development of adhesions. The adhesionsare caused by mechanical irritation of the tissue when the powderparticles are sequestered in the surgical site.

Such complications in the surgical site have been instrumental in thedevelopment of glove coating alternatives for gloves which are used forsurgical procedures. Such alternatives replace gloves which are coatedwith powdered talc or corn starch, with powder free gloves which arecoated with a powder-free coating.

Balanced against the disadvantages of using surface powders such astalc, cornstarch, and oat starch, is the advantage that surface powdersassist in mitigating the inherent tackiness of most elastomers, as wellas in facilitating donning the gloves. In order to detackify thenon-wearer-contacting surface of the elastomer glove, a detackifyingagent needs to be applied to that surface as well. A detackifying agentcan be applied to the non-wearer-contacting surface as part of normalprocessing of a glove disposed on a glove former, to which powder isapplied at the wearer-contacting surface. Such gloves can be strippedfrom the substrate-forming mold after being coated with powder, and canbe subsequently processed in a tumbler in order to more evenlydistribute the powder and/or to remove any excess powder. During suchtumbling, some of the powder is dislodged from the inner surface of theglove, and contributes to the powdering of the outer surface of theglove. Thus, by the time the glove has passed through the tumblingprocess, powder is present on both the wearer-contacting surface of theglove and on the wearer non-contacting surface of the glove. Typically,and desirably, there is more powder on the inner surface of the glovethan on the outer surface of the glove. The powder on the inner surfaceof the glove prevents the glove from sticking to itself and aids in thedonning of the glove. The powder on the outer surface of the gloveprevents adjacent gloves, e.g., in a box of gloves, from sticking toeach other. Thus, the surface powders, when acting as detackifiers,reduce the tendency of a glove to stick to itself such as on the insideof the glove, and to stick to other gloves when a plurality of glovesare tightly packed together in glove dispensers, or boxes of gloves.Thus, it is seen that the surface powder coatings act as detackifiers toprevent the surfaces of the gloves from sticking to each other, eitherwithin a given glove, or glove-to-glove. In addition, the surface powdercoatings act to facilitate donning of the gloves.

Use of a powdered donning lubricant such as talc, cornstarch, or oatstarch is preferred by some glove users, over lubricant coatings appliedto the wearer-contacting surface of the glove or to powder free gloves,in some respects because powder-based donning lubricants are effectiveto reduce frictional forces which must be overcome when the glove is puton/donned by the user.

Some fabricators of gloves have used halogenation, such as chlorination,and neutralization to solve the tackiness and donning issues of gloveswhich employ elastomer-based substrates. Other fabricators of gloveswhich employ elastomer-based substrates have used other surfacetreatments such as powder free glove coatings using alternativelubricants, for example silicone treated gloves, polyurethane treatedgloves, gloves treated with a polymer coating such as an acryliccoating, to solve the aforementioned problems with tackiness, as well asto address the issues attending powder-coated gloves in surgical uses.Such surface treatments typically include coatings applied to thewearer-contacting surface of the glove.

A coating is a material which provides an additional functionallyeffective layer, whether continuous or discontinuous, on the surface ofthe glove. Where the coating is discontinuous, generally the coating isprovided by a powder which is resident on the inner surface of the gloveas well as being optionally resident on the outer surface of the glove.The quantity of the powder, or rate of addition per unit area of theglove, is typically higher on the inner surface of the glove than on theouter surface of the glove.

Where the coating is continuous, the coating is typically defined as acontinuous film which has been deposited on at least one of the innersurface and the outer surface. In a film-type coating, the rate ofaddition per unit area is typically directly related to the thickness ofthe coating whereby the relative quantity of coating material on theinner surface and the outer surface can be related to the relativethicknesses of the coatings on the respective surfaces. Similarly, theuniformity of the coating can be determined by measuring the thicknessof the coating at various locations on a given surface.

In light of the issues related to skin problems with elastomeric gloves,there exists a demand for gloves which have improved coatings, bothpowder coatings and non-powder coatings.

There further exists a demand for coatings which use less coatingmaterial while achieving the combined objectives of ease of donning theglove and reducing the cost of the coating.

There also exists a demand for coatings which are less costly to produceper unit mass, and which can be employed in less mass per glove.

There still further exists demand for coatings which can be produced inthe same geographical regions where high volumes of glove substrates arebeing produced.

There exists yet additional demand for gloves which provide pleasanttactile feel to the wearer of the glove.

There exists yet further demand for coatings which address andameliorate skin problems which purportedly can attend use of suchgloves.

There exists a yet further demand for coatings which address andameliorate the skin problems which commonly attend use of such gloves byincorporating in the coatings material which is pharmaceuticallyeffective as a skin protectant in treating the types of skin problemswhich are commonly developed by people who use such gloves forsubstantial portions of their work days.

BRIEF SUMMARY

The gloves disclosed herein meet many of the demands listed above. It isnot required that any one embodiment meet all of the above demands.While certain embodiments exhibit improvements in several of the abovedemand features, this disclosure and claims herein extend to anyembodiment that achieves improvement in at least one of the above demandfeatures.

To that end, a first embodiment of gloves includes a polymeric glovesubstrate according to conventional technology, which is generallyimpermeable to biological fluids, tissues, and solids which are producedby the body. The glove substrate can employ a single layer of substratematerial, or multiple layers of substrate material. Where multiplelayers of substrate material are used, the substrate layers may all havesubstantially the same composition, or can employ differentcompositions. The glove substrate is coated on the inner, wearer-contactsurface, with a powder coating. The powder coating is defined largely bypowdered rice starch. The rice starch particle size is quite small, suchas about 2 to 8 microns, whereby the tactile feel of the coated glove isquite pleasant to the skin. The particle size of rice starch is aboutthree times smaller in average size in comparison to cornstarch so thereis a significant improvement in the tactile feel of the glove.

In a second and related embodiment of powder coated gloves, colloidaloatmeal powder is added to the rice starch. The colloidal oatmeal powderused is optionally a United States Pharmacopoeia (USP) grade colloidaloatmeal powder, and is optionally used in the coating composition in aquantity which makes a pharmaceutically effective skin-protectantpresentation to the skin, whereby the pharmaceutical benefits of thecolloidal oatmeal powder can be achieved. By giving colloidal oatmeal aUSP designation, the United States Food and Drug Administration hasrecognized that colloidal oatmeal is an over-the-counter drug that healsand protects the skin.

In a third and also related embodiment, the colloidal oatmeal powder isincorporated into a water-based carrier liquid. Supernatant portions ofthe resulting liquid composition can be referred to as “colloidaloatmeal enhanced water” (COEW). COEW can be employed as a coating on avariety of products which have elastomeric substrates, or otherpolymeric substrates, and especially products which effectively comeinto contact with a user's skin or other sensitive body tissues forprolonged periods of time. Various methods/processes can be used toapply a coating of COEW onto a polymeric substrate. The substrate can bedipped into a bath of the COEW, passed under a cascade of the COEW, orthe substrate can receive a spray application of the COEW. The COEW canbe incorporated into a mold release liquid bath. The gloves can betumbled in a tumbler in the presence of COEW. Where the substrate isavailable in a sheet-like form, the coating can be applied by any of themethods which are generally known for coating sheet stock such as in thepaper coating industry or the plastic film industry. Those skilled inthe art are aware of various other methods of applying a liquid coatingto a polymeric substrate. The substrate can also be pre-treated, such aswith various primer materials, or can be irradiated or corona treated toenhance adhesion of the COEW if and as desired.

In a fourth and also related embodiment, the COEW is coated onto anelastomeric glove substrate, especially onto that surface of the glovesubstrate which will form the inner surface, the wearer-contact surface,of the glove. The combination of the mass per unit of area of thecoating, and the concentration of the colloidal oatmeal in the COEW, aresufficiently great that the quantity of colloidal oatmeal which ispresented to the skin is effective to protect from, to treat for, and/orto attenuate, the various skin issues which can attend suchextended-time use of such gloves.

In a fifth and also related embodiment, a beta glucan solution (BGS) isused to coat an elastomeric glove substrate, especially onto thatsurface of the glove substrate which will form the inner surface, thewearer-contact surface, of the glove. The combination of the mass perunit of area of the coating, and the concentration of the beta glucan inthe coating, are sufficiently great that the quantity of beta glucanwhich is presented to the skin is effective to protect from, to treatfor, and/or to attenuate, the various skin issues which can attend suchextended-time use of such gloves. In addition, the beta glucan gives thegloves a silky feel when donning and provides a residue on the hands ofthe user that provides a silky feel on the user's skin even after thegloves are removed from the user's hands. Oat beta glucan is onespecific example of a suitable beta glucan that may be used tomanufacture BGS.

In a sixth and also related embodiment, COEW and BGS are mixed to form aliquid referred to herein as Polycoat. Polycoat may be coated onto anelastomeric glove substrate, especially onto that surface of the glovesubstrate which will form the inner surface, the wearer-contact surface,of the glove. The combination of the mass per unit of area of thecoating, and the concentration of the colloidal oatmeal and beta glucanin the Polycoat coating, are sufficiently great that the quantity ofcolloidal oatmeal and/or beta glucan which is presented to the skin iseffective to protect from, to treat for, and/or to attenuate, thevarious skin issues which can attend such extended-time use of suchgloves. The inclusion of Colloidal Oatmeal USP in Polycoat providesmedical benefits to the skin of the user of the glove. In addition, thebeta glucan in the Polycoat gives the gloves a silky feel when donningand provides a residue on the hands of the user that provides a silkyfeel on the user's skin even after the gloves are removed from theuser's hands.

The size of particulates in the liquid coatings that include COEW, BGS,or both (Polycoat) is preferably controlled to be less than apredetermined maximum particle size. As a result, a coating that usesthese materials results in a fine powder that aids in donning the glove,but the powder is not detectable using the standard ASTM D6124 test,resulting in a glove that may be easily donned due to the fine powdercoating but still qualifies as a powder-free glove under industrystandards.

The foregoing and other features and advantages will be apparent fromthe following more particular description, as illustrated in theaccompanying drawings.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

The disclosure will be described in conjunction with the appendeddrawings, where like designations denote like elements, and:

FIG. 1 shows a perspective view of one embodiment of a powder-coatedelastomeric glove;

FIG. 2 shows a cross-section of the glove of FIG. 2;

FIG. 3 shows one method of applying the powder coating to gloves;

FIG. 4 shows a perspective view of one embodiment of a non-powder coatedglove;

FIG. 5 shows a cross-section of the glove of FIG. 4, taken along theline 4-4;

FIG. 6 is a flow diagram of a method for manufacturing colloidal oatmealenhanced water (COEW);

FIG. 7 is a flow diagram of a method for manufacturing beta glucansolution (BGS); and

FIG. 8 is a flow diagram of a method for manufacturing an elastomericarticle that includes a powder-free coating derived from COEW, BGS orPolycoat.

The disclosure and claims herein are not limited to the details ofconstruction or the arrangement of the components set forth in thefollowing description or illustrated in the drawings. The disclosure andclaims are capable of other embodiments or of being practiced or carriedout in other various ways. Also, it is to be understood that theterminology and phraseology employed herein is for purpose ofdescription and illustration and should not be regarded as limiting.

DETAILED DESCRIPTION

The botanical sources of rice starch are generally defined by the genusoryza, typically from the species sativa, alternatively the speciesglaberrima. However other species are known, and are included in thedefinition of rice herein. As used herein, the term “rice starch”includes the named species rice and other species of the rice plant, asis known in the art. The preferred dry powdered rice starch is ricestarch powder commercially available as a freeze-dried powder or adehydrated powder. Rice starch is readily available from a wide varietyof commercial sources. The sizes of rice starch powder particles cover asubstantial size range, with average particle size generally in therange of about 2 microns to about 8 microns.

Referring now to FIGS. 1 and 2, a flexible impermeable elastomeric gloveis designated generally as 10. As shown in FIGS. 1 and 2, glove 10 hasan outer surface (non-wearer-contacting surface) 12 and an inner orwearer-contacting surface 14 and the elastomeric glove substrate 16therebetween. Substrate 16 can include one or more layers of elastomeror blended elastomers. As best shown in FIG. 2, wearer-contactingsurface 14 has a dry powdered material 18 applied thereto. Dry powderedmaterial 18 is typically dry powdered rice starch, or predominantly drypowdered rice starch. The particles in FIGS. 1 and 2 are not drawn toscale. Glove 10 is made generally as follows. A dry flexible glovesubstrate is oriented with the dry wearer-contacting surface facingoutwardly, such as on a glove mold. Dry powdered material 18 is appliedto the dry but tacky flexible elastomeric glove substrate at thethen-outwardly-facing wearer-contacting surface. The glove is invertedso the wearer-contacting surface is facing inwardly in the resultingglove. Dry powdered material 18 is applied while the wearer-contactingsurface is facing outwardly using any suitable application method,including without limitation aerosol application, electrostaticdeposition, tumbling, use of a powder bed, either fluidized bed ornon-fluidized bed. Other methods of applying dry powdered material 18will be known to those skilled in the art.

The percentage concentration of dry powdered material 18 on the surfaceof glove 10 ranges from about 0.0005 percent by weight to about 3.0percent by weight of dry powdered material, based on the weight ofsubstrate material 16. In some embodiments, dry powdered material 18 isabout 0.02 percent by weight to about 1.5 percent by weight based on theweight of the substrate material, with the most preferred being 1.35percent by weight. The coating weight range percentage can be adjusteddepending on the type of glove made and proprietary process nuances.Certain gloves may require up to about 25 percent by weight or greaterof dry powdered material 18 based on the weight of the glove substrate.

For a batch of 8,000 to 10,000 medical examination gloves preferablyabout 1 kilogram of dry powdered material 18 is used. The percentage forthe dry powdered material 18 can also be determined by industrystandards or guidelines, such as by ASTM Standard D6124 (ASTMInternational, West Conshohocken, Pa. 19428-2959, United States) forgloves. Dry powdered material 18 serves as a moisture regulator, as alubricant, and as a donning agent and, depending on the composition ofmaterial 18, may impart a range of therapeutic benefits and comfort tothe wearer. The therapeutic benefits of rice starch are discussed in a2002 article by Darin Engles which was published as a HealthnotesNewswire on the website for the Bastyr Center for Natural Health.

One advantage of the dry powdered material used to coat gloves is thatdry powdered material 18, when applied to the glove substrate, provideseven greater apparent lubricity characteristics than known powdercoating materials such as cross-linked corn starch due to the smallerparticle size.

A further advantage is that the rice starch particles do not bind tolatex proteins from natural rubber latex as readily as cross-linkedcornstarch. Another advantage is that rice starch is not cross-linked,thereby reducing the number of steps necessary in the production of thepowdered coating material. In addition, the therapeutically importantmolecules in dry powdered material 18 are not deactivated by a heatingstep. Thus, the full potency of the therapeutically important moleculesof dry powdered material 18 are available from glove 10. In the globaleconomy, such therapeutic potency can define a competitive edge in themarket. Substrate 16 of glove 10, having the dry powdered material 18applied thereon, can be either a single layer substrate, or amultiple-layer substrate. In a multiple-layer substrate, all of thelayers can have a common composition, or one or more of the layers canhave compositions which are different from the compositions of one ormore other ones of the layers. The specific layer compositions for glovesubstrate 16 can be well selected by those skilled in the art who arefamiliar with substrate compositions and methods for fabricating suchsubstrates for a specific glove application.

Dry powdered material 18 (which includes substantially dry powdered ricestarch) may permissively, but not necessarily, be fortified withcolloidal oatmeal. Colloidal oatmeal is a commercially available productwell known in the art, and generally is represented by the productresulting from comminuting whole grains of oats to a desired averageparticle size of 4 microns to about 30 microns. Colloidal oatmeal istypically added in an amount of at least 0.003 percent by weight,optionally at least about 10.0 percent by weight, based on the totalweight of the powder coating material.

In addition, or in the alternative, powdered material 18 can be furtherfortified with one or more commercially available additives, in additionto the optional addition of colloidal oatmeal, which are known toprotect and restore mammalian tissue such as skin or other membranes.Suitable additives 20 which may be included in powdered material 18include, without limitation, any one or more of Vitamin A, Vitamin B3,Vitamin B5, Vitamin C, Vitamin E, jojoba, rose hips, aloe vera, driedtea tree oil, dried flax seed oil, dried palm oil, and acetylsalicylicacid. Such additives may be added in amounts to meet content labelingrequirements known in the industry.

Optionally, the dry powder material coating contains rice starch,preferably as a predominant component, and may include colloidal oatmealas well as any, or any combination, of the known additives which areknown to protect and/or restore mammalian tissue. The most preferredadditive ingredient is colloidal oatmeal, with secondary preference forVitamin E. In some implementations, the powdered rice starch canfunction as a delivery agent for additive 20, maximizing thebioavailability of additive 20, as well as optionally contributing,itself, to the protection and/or restoration of the tissue beingtreated.

Hand sweating beneath a glove, with extensive use of such gloves, isknown to be a contributor to irritant contact dermatitis.Advantageously, rice starch provides better water absorption properties,compared to cornstarch, silicone and polyurethane which are commonlyused as donning agents. The ability to absorb the perspiration withoutabrasive properties, while reducing the cost of the powder coatingmaterial, is an advantage over known art. The cost per weight unit ofthe powder coating 18 is typically more than cross-linked cornstarch,but less powder coating 18 is required than the cross-linked cornstarch,resulting in a net reduction in the cost of powder on a glove. Theimprovement of therapeutically protecting the skin is a function of theability of dry powder 18 to overcome water homeostasis after glove 10 isdonned by a wearer.

As can be appreciated by those skilled in the art, other dry powderedmaterials can be used in combination with dry powdered rice starchand/or dry powdered colloidal oatmeal. These materials can include, forexample and without limitation, one or more dry powdered plant materialssuch as okra, kelp, tamarind, psyllium, carrageenan, chia, flax, carob,guar, xanthan, konjac, cassia, tara, karaya, ghatti, tragacanth,glucomannan, or galactomannan. Such dry powdered materials arecommercially available, for example, from NHK Laboratories, Inc., 12230E. Florence Ave., Santa Fe Springs, Calif. 90670-3806 (866) 645-5227;Aloe Laboratories, 5821 East Harrison, Harlingen, Tex. 78550 (956)428-8416; Voigt Global Distribution LLC, P.O. Box 412762, Kansas City,Mo. 64141-2762 (877) 484-3552; Natunola Health, 661 St. Lawrence Street,Winchester, Ontario, Canada KOC 2K0 (613) 774-9998; P. L. Thomas, 119Headquarters Plaza, Morristown, N.J. 07960 (973) 984-0900; KingreatChemistry Co., Ltd., Jinyuan Plaza 57, Hubin Road(S), XIAMEN, Fujian,China 361004 86-592-2299-609; Konjac Foods, 355 W. Olive Ave., Suite104, Sunnyvale, Calif. 94086 (408) 257-1813; Glucomannan.com, 20432Silverado Ave., #212, Cupertino, Calif. 95014; Cognis UK Ltd.,Charleston Road, Hardley, Hythe, Southampton, Hampshire, SO45 3ZG UnitedKingdom.

In a method of making flexible elastomer glove 10, a cleaned ceramicglove mold is passed into a dip tank containing mold release agent. Theso-coated mold is then passed through an oven to bring the mold to thedesired coating temperature. The mold is then dipped in, passed through,an open-topped tank of liquid which contains latex which is to be usedto form a glove substrate on the mold. The so-coated mold is passedthrough an oven to accomplish pre-vulcanization of the latex rubberwhich has been coated onto the hand-shaped mold. The mold, with thelatex coating thereon, is then contacted with a leaching agent, forexample in another open top tank, to wash off excess uncured latex andresidual monomer, as well as to reduce protein content of the latex. Theglove substrate so formed, still on the mold, is then passed through atank which applies powder 18, as a water slurry coating, to the outersurface of the tacky latex substrate. The coated glove is then passedthrough another drying oven, which further cures the latex as well asdriving off the water carrier from the powder-coating slurry.

The so-coated glove is then stripped from the mold, and is inverted inthe stripping process, such that the previously-outside surface of theglove on the mold becomes the inner surface of the inverted glove. Theglove can then be put in a tumbler/dryer for final drying andvulcanization. During the tumbling action, some of the powder, now onthe inner surface of the glove, becomes dislodged, moves outside theinside enclosed area of the glove and becomes lodged on the outer,non-wearer contacting, surface of the glove, thereby to lubricate suchouter surface.

The dry flexible elastomeric glove substrate, made according to theabove glove manufacturing process, is oriented such that the drywearer-contacting surface is disposed/directed outwardly, so asefficaciously to receive dry powdered material 18 as such dry powderedmaterial 18 is applied to the wearer-contacting surface. Dry powderedmaterial 18, such as dry powdered rice starch with or without theaforementioned colloidal oatmeal or additives 20 or plant materials, istypically applied to the dry wearer-contacting surface of the dryflexible elastomer glove.

Starting with the glove on the ceramic glove mold, glove 10 isultimately inverted such that the outer surface, namely thenon-wearer-contacting surface 12, is facing outwardly relative to theglove, and the wearer contacting surface 14 is directed inwardly intothe glove as shown in FIG. 1. After the glove is thus coated, and afterthe glove is inverted as the glove is being removed from the mold, glove10 is further processed according to known-in-the-art glove finishingprocesses which do not require the addition of moisture and whichoptionally do not require application of heat to the glove.

Any flexible elastomer article can be produced according to the samemethod. For example, a dry elastomer article is made according to knowntechniques and is oriented with the wearer surface facing outwardly awayfrom the article. Dry powdered material 18, such as dry powdered ricestarch and optionally dry powdered colloidal oatmeal, with or withoutany additives 20, is applied to the dry wearer-contacting surface of thedry elastomer article. The article is inverted and may undergo furthertumbling and/or other processing as described for gloves and/or as istypical for such articles.

The amount of the dry powdered material used is in a quantity sufficientto meet industry standards or guidelines, such as, but not limited to,the International Starch Institute criteria for residual rice starch inthe article, the aforementioned ASTM standards, as well aspublicly-known glove industry standards. The quantity of dry powderedrice starch material ranges from about 0.0005 percent by weight to about3.0 percent by weight of dry powdered rice starch material, preferablyabout 0.02 percent by weight to about 1.5 percent by weight dry powderedrice starch material 18, based on the weight of the substrate material.

An exemplary method of applying the dry powdered rice starch material toa dry wearer-contacting surface of a dry flexible elastomer gloveincludes selecting a dry flexible elastomer glove oriented to receive amaterial to be applied to a dry wearer-contacting surface of the glove.The glove is optionally still on the ceramic substrate former mold. Thedry powdered material 18, with or without colloidal oatmeal or additives20, is applied to the outwardly-facing dry wearer-contacting surface ofthe glove by any suitable method, including without limitation aerosolapplication, electrostatic precipitation, tumbling, passing the glovesubstrate through a bed, either fluidized or non-fluidized, of the drypowdered material, or dipping the glove substrate in a tank of liquidwhich contains the coating powder in a slurry.

In a specific exemplary method, dry powdered material 18 is aerosolizedusing pressurized nozzles disposed in a negative pressure chamberthrough which the dry gloves pass, still on the substrate formers. Thedry powdered material adheres to the surface of the elastomer (polymer)material of the glove because of the inherent tackiness of the elastomermaterial. The dry powdered material is in a fine cloud form having aparticle size typically about 8 microns or less, more typically about 6microns or less. In general, the smaller the particle sizes result ingreater wearer perception of improved lubricity in donning the glove 10.In addition, smaller particle size typically means that relatively lessdry material is used, compared to a powder which employs larger-sizeparticles.

The quantity of dry powdered material 18 deposited is generallyproportional to the aerosolized concentration of dry powdered materialin the negative pressure chamber and the length of time in the chamber.Typically, about 2 kilograms of the dry powdered material is used for8,000-10,000 gloves. After the gloves are so powder-coated, the glovesare removed from the powder-coating chamber and each glove is invertedas it is pulled from the former, such that the resulting powder-coatedgloves are oriented with the coated surface on the inside of the glove.It will be understood that a lesser weight portion of the coating isalso resident on the now outwardly-facing surface of the glove.

In another exemplary method, the dry powdered rice starch material canbe electrostatically applied to a dry wearer-contacting surface of a dryglove. A completely dry glove is disposed on a glove former. Anelectrostatic charge is applied to the glove former whereby there is adifference in charge between the former and the glove surface. Theelectrostatic charge creates a static charge difference between thewearer-contacting surface of the glove and dry powdered material 18. Thedry powdered material, with or without the colloidal oatmeal oradditives 20, is applied in aerosol form, as an aerosolized dry powder,to the glove while the glove is on the former. The charge differenceattracts the aerosolized powder to the wearer-contacting surface of theglove. The electrostatic deposition process holds potential for lesswaste of the dry powdered material in the powder deposition step,thereby reducing cost of material. Since the powder is better controlledby the electrostatic process than in the reduced pressure process, theelectrostatic process, including dust control, can be easier to managein the manufacturing setting. Alternatively, rather than applying anaerosol form of the dry powdered material 18, with or without thecolloidal oatmeal or additives 20, the glove is sprayed or dusted withthe dry powdered material until the dry wearer-contacting surface of theglove is covered with the dry powdered powder. Again, each glove isinverted as it is pulled from the former, after being coated with thepowder.

In yet another different process, dry powdered material 18 is applied tothe dry glove by tumbling the dry powdered material 18 with the dryglove in a tumbling chamber of a glove tumbler, as shown in FIG. 3. Asis known in the art, in some glove making processes, a glove is dried ina glove tumbler with the dry glove oriented in such a manner that thedry wearer-contacting surface is facing outwardly. The dry powdered ricestarch material, with or without colloidal oatmeal or the dry additives,is added to the glove tumbler. Dry powdered material 18 can be in anaerosol form as disclosed above, or in a non-aerosol form when added tothe tumbling chamber. The gloves are tumbled until the dry powdered ricestarch material covers the gloves, for approximately 2-5 minutes for8,000 to 10,000 gloves, using approximately 2 kilograms of the drypowdered material.

During the tumbling operation, the dry wearer-contacting surface of eachglove is facing outwardly and is put into the glove tumbler with the drypowdered rice starch material and tumbled without applied heat until thedry powdered material generally uniformly covers the drywearer-contacting surfaces 14 of the gloves 10. The gloves are invertedafter tumbling so that the coated non-wearer-contacting surface 12 isdisposed outwardly as shown in FIG. 1. In tumbling processes, as well asin the aerosolized processes, some of the dry powdered material adheres,as well, to the non-wearer contacting surface 12.

Still yet alternatively, in a glove stripping station, a bed of the drypowdered material 18, with or without additives 20, is disposed alongthe production line. The bed of dry powdered material 18 can benon-fluidized or fluidized. A fluidized bed means that the dry powderedmaterial is aerated so as to facilitate passage of a material or articlethrough the bed. Namely, air is caused to bubble up through the drypowdered material. The gloves pass through the bed of dry powderedmaterial 18 whereby the gloves are coated with the powder. Each glove isinverted, as usual, as the glove is removed from the mold. The amountsof the dry powdered material 18 which are coated onto the gloves are asdescribed above.

The mean and median particle size of the un-crosslinked native ricestarch powder used in powdered material 18 is smaller than the mean andmedian particle size of the cross-linked powdered corn starch used inthe prior art. This smaller particle size results in a number ofbenefits. First, since the uncross-linked rice starch particles aresmaller, the typical amount of rice starch powder material which is usedis less than the amount of cross-linked corn starch material which wouldbe used on the same glove. Second, uncross-linked rice starch is readilyavailable in Asia where many latex glove substrates are made. Third,since the particle size of the rice starch is relatively smaller, thefeel of the glove is that of a relatively smoother, finer-texturedcoated surface of the glove. Fourth, where USP-grade colloidal oatmealis used in combination with the rice starch, the USP pharmaceuticalbenefits of the colloidal oatmeal further address protection of theuser's skin from skin problems such as those discussed above.

FIGS. 4 and 5 illustrate a powder free glove 400. Glove 400 includes aninner cavity that defines an inner surface 440 that contacts thewearer's hand and an outer surface 420, as shown in FIG. 5. Either orboth of surfaces 420 and 440 may include a dry coating, shown in FIG. 5as a layer 510 on the outer surface 420 and a layer 520 on the innersurface 440. Note that layer 510 on outer surface 420 is optional forsome glove applications, but many manufacturing methods for applyingcoating layer 520 to the inner surface 440 may also produce a residualcoating layer 510 on the outer surface 420 as well. As used herein,“powder free” means that the gloves, on average, have less than 2milligrams of particulate, when tested according to ASTM D6124.

In a powder free glove, the publicly recognized purpose of the glovecoating is to facilitate donning of the glove by a lubricityfunctionality. Synthetic polymer based coatings, such as acryliccoatings, are well known for use as the lubricity agent for facilitatingdonning of the glove. An additional purpose is to provide protection tothe user's skin. To that end, a colloidal oatmeal extract may be coatedonto the polymer coating, with the result that the polymer coatingprovides lubricity and the colloidal oatmeal extract provides skinhealing and protection properties which are activated by perspirationfrom the user's skin. However, in the most preferred implementation of apowder-free glove, the colloidal oatmeal extract provides both thelubricity functionality and the skin protectant functionality, wherebythe polymer coating can be omitted.

Additional plant starch components can be combined with the colloidaloatmeal extract in order to provide other benefits such as costreduction, additional starch proteins, film forming benefits, and thelike.

Where the skin benefits which attend colloidal oatmeal are not necessaryto the functionality required of a particular glove, the powder freeextract can be made from any of a wide variety of powdered grains,either taken alone or in combination, whether whole grain or the starchextract of such grain. Thus there can be mentioned, for example andwithout limitation, rice and rice starch, corn and corn starch, amaranthand amaranth starch, oat and oat starch, and the like. For example, ricestarch can be substituted in whole or in part for colloidal oatmeal,thus to form a lubricity coating. Rice starch can be combined withcolloidal oatmeal to form a lubricity coating which provides theadditional skin protectant functionality.

One version of the powder-free glove disclosed herein includes a coatingthat includes colloidal oatmeal that has been processed to extract manyof the beneficial qualities of colloidal oatmeal while eliminatingnearly all of the powder in the coating. As a result, the benefits ofcolloidal oatmeal may be enjoyed in a powder-free coating on a glove orother elastomeric article. Colloidal oatmeal USP is recognized as aproduct which is capable of healing and protecting the skin. Colloidaloatmeal USP is classified by the United States Food and DrugAdministration (FDA) as an over-the-counter drug due to its ability toheal and protect the skin. Other coatings for gloves are currently notclassified by the FDA as over-the-counter drugs.

The beneficial components of colloidal oatmeal are:

1) Polysaccharides—Colloidal oatmeal has a high polysaccharide contentand forms a gelatinous hydrocolloid in water, which leaves a protectivefilm on the skin that physically retards water loss. Additionally, thisfilm helps to repair and maintain the epidermal barrier.

2) Oat lipids—These agents add to oatmeal's moisturizing,barrier-enhancing properties.

3) Oat proteins—These proteins have the ability to buffer both acids andbases that aid in barrier maintenance and repair.

4) Saponins—These ingredients within oatmeal help to solubilize dirt,oil and sebaceous secretions.

Referring to FIG. 6, a method 600 for making colloidal oatmeal enhancedwater (COEW) starts by mixing colloidal oatmeal powder with water toform a slurry (step 610). The slurry is then mixed at a predeterminedtemperature for a predetermined period of time (step 620). The mixing instep 620 allows many of the beneficial properties of colloidal oatmealto be extracted from the colloidal oatmeal into the water in apowder-free form. The slurry is then cooled (step 630). The remainingparticulate material above a selected maximum particle size is thenremoved, resulting in colloidal oatmeal enhanced water (COEW)concentrate (step 640). To produce what is defined as a powder-freeglove, the FDA states there needs to be less than 2 milligrams of totalparticulate on the finished glove per the ASTM test D6124. The COEW thatresults from method 600 is a liquid coating that may be applied togloves and then dried to provide a powder-free coating which providesmany of the beneficial properties of colloidal oatmeal in a powder-freeform. Note that the term “powder-free” as used in the specification andclaims herein does not mean the complete absence of powder in thecoating, but instead denotes a concentration of powder in the coatingthat is sufficiently small to meet government and/or industry standardsfor a powder-free glove.

The predetermined particle size in the slurry that is removed in step640 of FIG. 6 may vary within the scope of the disclosure and claimsherein. The predetermined particle size is 2.0 micron, is morepreferably 1.5 micron, and is most preferably 1.0 micron. Thus, step 640in FIG. 6 removes most of the particles above a predetermined particlessize, however that predetermined particle size may be defined. Note,however, that step 640 may not remove every single particle above thepredetermined size. The resulting COEW may also include a concentrationof particles above the predetermined size that is less than apredetermined threshold. This allows some very small amount of particlesabove the predetermined size to be present in the COEW, so long as theamount still results in a powder-free glove.

In the past, colloidal oatmeal has been used as a dry donning agent ongloves. The Ostar glove, which has been commercially available since1996, used a dry powder derived from colloidal oatmeal powder as acoating. Colloidal oatmeal is a well-known skin conditioning substance,skin moisturizing substance, skin softening substance, skin nourishingsubstance, skin emollient substance, and skin anti-inflammatorysubstance. Colloidal oatmeal is a powdered product which, if put onto aglove in an amount which would allow it to be effective in protectingand healing skin, would cause the glove to exceed the powder limits fora powder-free glove.

A detailed process for making COEW concentrate is now presented as onespecific implementation of method 600 in FIG. 6. The colloidal oatmealUSP must go through a process where the beneficial components of thecolloidal oatmeal are extracted from the grain particle into a watercarrier. The extraction process is most efficient if the colloidaloatmeal powder, which is typically 4 to 30 microns in size. Note thatthe colloidal oatmeal powder could be further reduced in size byadditional milling or filtering within the scope of the disclosure andclaims herein. One part colloidal oatmeal is mixed with nine partsionized water, by weight, to form a slurry. The water temperature ispreferably between 35 to 49 degrees Celsius, more preferably between 40to 49 degrees Celsius, and is most preferably between 45 to 49 degreesCelsius. A temperature in excess of 49 degrees Celsius will cause thecolloidal oatmeal slurry to gel, and causes some or all of the activeingredients in the colloidal oatmeal to be denatured. For this reason,the temperature is preferably kept less than 50 degrees Celsius. Themixture is preferably mixed vigorously at as high a speed ascommercially viable. The mixing equipment is preferably able to cut andshear the mixture as it mixes. The mixing time is at least 15 minutes,preferably at least 30 minutes, and most preferably at least 60 minutes.Temperature should be maintained between 45 to 49 Celsius as the slurryis mixed. Once the mixing is complete, the remaining particulate that isabove a predetermined particle size is removed from the slurry. This maybe done in any suitable way. For example, one way to remove theundesired particulate uses a decanter type centrifuge. Another way toremove the undesired particulate is by allowing the remaining oatparticulate material to settle to the bottom and separating the liquidfrom the settled particles, either by extracting the resulting COEWconcentrate from the top or by forcing the particles out the bottomuntil there is only liquid left. Yet another way to remove the undesiredparticulate is by filtering the mixture, thereby producing COEWconcentrate. The resulting COEW concentrate contains the beneficialproperties of Colloidal Oatmeal USP, as described in DEPARTMENT OFHEALTH AND HUMAN SERVICES, Food and Drug Administration, 21 CFR Parts310, 347, and 352, Docket Nos. 78N-0021 and 78N-021P, RIN 0910-AA01,Skin Protectant Drug Products for Over-the-Counter Human Use. As aresult, the COEW concentrate may be applied to a glove, then dried,resulting in a glove that provides beneficial concentrations ofingredients of colloidal oatmeal in a form that may be used to produce apowder-free glove.

The COEW is preferably applied to an elastomeric article in aconcentration of 100%, but the viscosity of COEW without furthermodification would not provide optimal results in a glove manufacturingprocess. Without further modification the COEW does not equally dispersenor does it adhere well to the surface of the glove. To overcome thisproblem, a cellulose based thickening agent that does not interfere withthe manufacturing process is preferably added to the COEW slurry. Thepreferred thickening agent is carboxymethylcellulose, which is added ata concentration of 0.1% to 0.5% by weight. Carboxymethylcellulose isavailable as Gabrosa DT 732 manufactured by Akzo Nobel Chemicals,available from the distributor Chung Chemicals SDN BHD A-42-3 Sri DesaEntrepreneurs Park, Jalan 1/116B, Off Jalan Kuchai Lama 58200,Telephone: 603 7987 7611.

COEW is highly susceptible to bacteria growth when in the liquid form.Once the COEW is applied to a glove and dried, there is typically noissue with bacterial growth in the dried COEW coating as long as thegloves are stored in a cool, dry place. If the COEW concentrate inliquid form needs to be stored or remains unused over a period of time,a suitable preservative (such as a bactericide) may be used to keep thebacteria in the COEW concentrate to an acceptable level. One suitablebactericide is commercially known as Biostat G7, which is commerciallymanufactured and marketed by Chempro Technology, Lot #27, Jalan LadaHitam 16/12, Kawasan MIEL, Phase VII, 40000 Shah Alam Selangor,Malaysia. Other preservatives such as diazolidinyl urea, iodopropynylbutylcarbamate and propylene glycol could be used. The specificproportions needed depend on the time of storing the COEW, temperature,etc. One suitable mix of preservatives is 0.07% chloracedamide and 0.03%sodium benzoate. One skilled in the art will realize that the specifictypes and amounts of preservatives may vary depending upon theparticular application.

Given the above method of making COEW concentrate, the COEW can be madein a variety of concentrations, with resulting protein contents asfollows. g. oatmeal/ Centri- Ex. 100 ml Mix Mix Heating Centrifuge fugeProtein No. H2O Time Temp Time RPM Time ug/g 1 .0115 1 min 44 C. 45 min2000 20 min 2.39 2 .313 1 min 44 C. 45 min 2000 20 min 2.04 3 10 1 min44 C. 45 min 2000 20 min 3.53 4 15 1 min 44 C. 45 min 2000 20 min 3.26 520 1 min 44 C. 45 min 2000 30 min 3.53 6 25 1 min 44 C. 45 min 2000 30min 3.95 7 30 1 min 44 C. 45 min 2000 30 min 4.47

Examples 1-4 remained turbid at 20 minutes centrifuge time. Increasingthe centrifuge time in Examples 5-7 produced a clear supernatant liquid.While a centrifuge was used in Examples 1-7, simply letting theparticulate matter settle out of the slurry is believed to provide anequally acceptable process.

Once the supernatant liquid (COEW concentrate) is obtained, the liquidcan be used without dilution, or can be diluted as desired. Using the 10gram/100 ml water addition rate for making the COEW concentrate inExample 3, the inventors herein have found a 5/1 dilution rate, namely 4parts water to 1 part COEW concentrate, to provide a dry coating whichconsists of 10 micrograms of protein per gram of dried COEW on theglove, using the ASTM 5712 Standard Test Method for Protein. A 5/2dilution rate provided a coating weight of 20 micrograms (ug) of proteinper gram of dried COEW on the glove.

Particle size in the resultant COEW is preferably relatively small. Inthe above Examples 1-7, particle size was 2 microns or less in thesupernatant COEW concentrate.

Another liquid may be used as a coating for elastomeric articles such asgloves. Beta glucan is a derivative that is available from many naturalsources, including oats, wheat barley, baker's yeast, and mushrooms. Themost preferred form of beta glucan is oat beta glucan that is availableas Nurture® Beta-Glucan 70 PC which is available from Nurture, Inc.,5840 Expressway, Missoula, Mont. 59808, 888-395-3300. This form of betaglucan is preferred because it is completely water-soluble. Referring toFIG. 7, a method 700 for producing a beta glucan solution begins bymixing beta glucan powder with water at a predetermined temperature in amanner that clumps do not form (step 710). The resulting mixture ismixed vigorously to produce beta glucan solution (BGS) (step 720). TheBGS may then be applied to gloves or other elastomeric articles, eitherfull-strength or in a diluted form. One of the benefits of using thisparticular form of beta glucan instead of colloidal oatmeal is that betaglucan is water-soluble. As a result, all of the beta glucan goes intosolution, which eliminates the need to remove particulate material (asis necessary in step 640 in FIG. 6 during the production of COEW).

Beta glucan is an excellent ingredient for glove coatings because betaglucan has been shown to stimulate collagen production, revitalize andrejuvenate skin, reduce stinging in alpha-hydroxy acid formulations, isan anti-inflammatory, and provides cellular protection againstultraviolet (UV) radiation. Note that not all beta glucan is completelywater-soluble. Some products are only partially water-soluble, and thewater-solubility may be specified as percentage. Beta glucan that is notcompletely water-soluble may also be used within the scope of thedisclosure and claims herein. If the beta glucan is not completelywater-soluble, the resulting mixture will be part-solution (for the partthat is water-soluble) and part suspension (for the part that is notwater-soluble). The term “beta glucan solution” and “BGS” as used in thedisclosure and claims herein expressly includes any liquid that containsbeta glucan that is either partly or completely water-soluble,regardless of whether or not the liquid contains particles in suspensionas well.

The BGS resulting from performing method 600 in FIG. 6 may be applied togloves full-strength, but is preferably diluted with water. The dilutionmay provide for a concentration of BGS of less than 50%, more preferablyless than 20%, and most preferably from 1-5%. Note that theconcentration of BGS may be any suitable concentration from less than 1%up to and including 100%, and will depend on the desired feel of theglove, where higher concentrations of BGS provide a more discerniblefeel on the hands of the user.

A detailed process for making BGS is now presented as one specificimplementation of method 700 in FIG. 7. For this example, we assume oatbeta glucan is used. Oat beta glucan is refined beta-glucan, defatted,un-denatured oat protein in the form of fine micro porous particles. TheINCI (International Nomenclature Cosmetic Ingredient) name for oat betaglucan is simple “beta glucan”. Glucans are polysaccharides made up ofchains of glucose molecules. The term “beta” refers to the stericposition of the glucose hydroxyl group involved in the chain formation.The terms beta-1,3- and beta-1,6-glucans are often used, with thenumbers referring to the positions on the glucose molecules that linkthem together. Beta-glucans are considered to be water-soluble fiber andare non-digestible, due to the absence in the human body of an enzymecapable of hydrolyzing the beta-glucosidic linkage. Some of the benefitsof oat beta glucan are:

1) Cellular protection against UV

2) Stimulates collagen production

3) Anti-inflammatory

4) Moisturization via humectancy

Oat beta glucan needs to be placed into a water carrier in order to beused in a glove manufacturing process. The steps required to mix oatbeta glucan in water are disclosed below.

A maximum of up to 2% oat beta glucan can be mixed with 98% ionizedwater, by weight. Concentrations of more than 2% will cause the BetaGlucan to not be completely soluble and it will settle out rather thanremain in solution. When mixing oat beta glucan and the water, thetemperature of the water is preferably 80 to 90 degrees Celsius. Thewater is preferably circulated in a mixing unit which causes a circularvortex in the water. The beta glucan powder is preferably added at thecenter of the vortex very gradually as not to allow any of the powder toclump. If the powder clumps it will not properly go into solution, andsome of the powder will remain in powder form in suspension in thewater. The mixture of water and oat beta glucan powder is preferablymixed vigorously at as high a speed as commercially feasible and viable.The resulting product is beta glucan solution (BGS).

BGS is highly susceptible to bacteria growth. Once the BGS is applied toa glove and dried, there is typically no issue with bacterial growth inthe dried BGS coating as long as the gloves are stored in a cool, dryplace. If the BGS in liquid form needs to be stored or remains unusedover a period of time, a suitable preservative (such as a bactericide)may be used to keep the bacteria in the BGS to an acceptable level. Thesame preservatives may be used with BGS that are listed above for COEW,namely Biostat G7, diazolidinyl urea, iodopropynyl butylcarbamate andpropylene glycol. The specific proportions needed depend on the time ofstoring the BGS, temperature, etc. One suitable mix of preservatives is0.07% chloracedamide and 0.03% sodium benzoate. One skilled in the artwill realize that the specific types and amounts of preservatives mayvary depending upon the particular application.

In one specific implementation, the COEW and BGS are mixed. When the twoare mixed, the resulting mixture is referred to herein as “Polycoat” torepresent that a dried coating of the liquid includes multiplebeneficial ingredients. Production trials using various combinations ofCOEW and BGS in the Polycoat show that the levels of BGS that can beused in the manufacturing process range from as low as 0.1% to up to 50%of the 2% concentrated solution. Various mixtures of the COEW and theBGS can then be used in the glove manufacturing process. The mixturepercentages used would be determined based on the desired outcome of theglove product. The range of mixtures of the COEW and the BGS could varyfrom 1% to 100% of the COEW and 0.1% to 50% of the BGS.

Referring to FIG. 8, a method 800 for manufacturing an elastomericarticle begins by forming the elastomeric article (step 810). Thearticle may be formed by any suitable method, whether currently known ordeveloped in the future. A liquid that includes COEW and/or BGS is thenapplied to the elastomeric article (step 820). There are many differentways to apply the liquid to the elastomeric article in step 820,including dipping, spraying, tumbling and spraying, etc. The liquid isthen dried on the article, resulting in a powder-free coating on theelastomeric article (step 830). If the article being manufactured is aglove, one suitable way to dry the liquid is to pass the gloves througha series of ovens designed to dry and cure the glove. This dryingprocess causes the dried coating to tightly bond with the glove surfaceso that it remains in tact until the glove is donned by the user.

The size of particulates in the liquid coatings that include COEW, BGS,or both (Polycoat) is less than a predetermined maximum particle size.As a result, a coating that uses these materials results in a finepowder that aids in donning the glove, but the powder is not detectableusing the standard ASTM D6124 test, resulting in a glove that may beeasily donned due to the fine powder coating but still qualifies as apowder-free glove under industry standards.

In the manufacturing of gloves, even distribution of the liquid (e.g.,COEW, BGS or Polycoat) on the glove surface maximizes therapeutictreatment of the hand and minimizes contact between the skin and theglove's composite material. Stationary drying is not preferred becausethe liquid tends to flow in the direction of the force of gravity. Inthe preferred manufacturing method the glove is spayed with the liquidcoating. In another method the glove can also be dipped into a tankcontaining the liquid coating. Whether sprayed or dipped, when the glovecomes away from the particular application process the porcelain glovemold rotates the glove as it passes through the drying ovens to make theliquid distribute evenly on the glove surface and to form a uniformcoating. This would be for an online manufacturing process but in a lesstechnologically advanced manufacturing facility where an on line methodof manufacturing is not possible, the gloves can be taken to an offlinetumbling dryer and the liquid can be sprayed on in the tumbler duringthe drying process.

In the preferred manufacturing method, once the gloves have passedthrough the drying ovens the gloves are then stripped from the porcelainglove molds using a process called air stripping. If air stripping isnot a feature of the manufacturing line the gloves can also be removedmanually from the porcelain glove mold former. In either strippingmethod the gloves are inverted so that the surface with the driedcoating is now on the inside of the glove or the side the glove the userwould primarily come in contact with.

The preferred method for the most cost efficient production of thecoated powder-free glove requires a fully automated production lineusing industry standard porcelain glove mold formers where the variousdescribed processes are accomplished. This more advanced automatedmethod is preferred and best suited for producing the gloves insubstantially larger quantities and at a lower cost.

The preferred method of manufacturing is fully automated within theproduction line, meaning that no (or minimal) offline steps arerequired. The gloves are formed on porcelain glove molds in a similarfashion to standard technology, but the primary difference being thatthe mold release agent, which is the substance the manufacture placesbetween the porcelain glove mold and the substrate material, is a powderfree, polymer material. In less automated facilities where less currenttechnology is available a powdered substance of calcium carbonate isused as the mold release agent. Once a powdered mold release agent isused there is no way to remove the unwanted mold release agent powderwithout removing the glove from the mold and taking it to some offlinetype of washing process. Typically this process requires that the glovesbe put into offline washing units where they are once again takenthrough a chlorination process. This causes unnecessary steps in themanufacturing process and increases the product cost which must bepassed to the glove consumer. The large purchasing groups which providegloves to the larger users of gloves like hospitals and nursing homesare extremely price sensitive. If the preferred method of manufacturing,a fully automated process is not used, very few of these types of gloveconsumers would be able to take advantage of a glove containing a skinprotecting and healing substance.

In this method the gloves which are formed on the porcelain glove moldcurrently are in an inside out position. So the surface which currentlyis the exterior surface when stripped from the porcelain glove mold andturned inside out will become the inside, or user side/surface of theglove which will come in contact with the user and deliver the dose ofbeneficial ingredients in the dry coating to the users skin.

To achieve a surface on the inside or users side of the glove, achlorination washing process is the common process for making thissurface slippery enough to allow the user to easily slip their hand intothe glove. There are other layers/surfaces that can be added to thegloves surface alone or in conjunction with chlorination on the userside of the glove such as acrylic polymers or silicone or polyurethaneto cause the glove to be more easily donned.

Following the application of an adequate donning surface, such as apolymer layer, the liquid (e.g., rice starch liquid, COEW, BGS orPolycoat) is applied to the gloves while the gloves are still on themolds, either by dipping or by spraying. If spraying is used, it shouldbe a sufficient dosage so as to leave a desired amount of solution onthe gloves' inside out surfaces. Dipping and spraying are very differenttypes of processes which will require unique viscosities for eachmethod. Viscosity required will depend upon many factors including thetype of layers/surfaces that have been added to the gloves surface aloneor in conjunction with chlorination on the user side of the glove suchas acrylic polymers or silicone or polyurethane to cause the glove to beeasily donned, and other manufacturing line considerations like thespeed of the line.

Following this application of the liquid the gloves go through a dryingprocess. In this preferred method, as the glove continues to travel downthe manufacturing line, circulating heated air will be moved around themolds which hold the partially vulcanized latex glove. As the glovecontinues to vulcanize with the coating adhered to the surface therubber partially bonds with the coating causing a tighter and longerlasting bond to form. From line to line temperatures will vary based onthe length available for drying purposes. Typical heating ranges from110 and up to 130 degrees Celsius.

The application of Polycoat to gloves needs to occur following steps inthe manufacturing process which causes the glove to be clean fromcontaminants and the steps which create the layers/surfaces that can beadded to the gloves surface alone or in conjunction with chlorination onthe user side of the glove such as acrylic polymers or silicone orpolyurethane to cause the glove to be more easily donned.

Contaminants are primarily the powders and airborne particulate found ina factory environment and the water soluble latex proteins and otherchemical residues like accelerators used to help vulcanize the gloverubber. In the preferred embodiment, due to cost considerations, anonline manufacturing method is preferred. Many glove manufacturers, dueto a lack of technology and equipment, must take the gloves off the lineto washers, tumblers and drying equipment to add other desired types ofsurface treatments, but in this preferred method the entire processtakes place online and thus there are significant cost savings. Theviscosity and concentration of the liquid coating is specificallydesigned to allow for an online application. In the preferredmanufacturing method, the online application of liquid coating is alsounique in that it is sprayed on versus dipped into a tank as in themajority of manufacturing operations. Although a dipping tank scenariowould be the easiest way to apply the coating, a dipping tank will causethe dangerous water soluble proteins found in the gloves to be leachedout into the liquid as each glove passes through the dip tank. Veryrapidly these allergenic water soluble proteins will build up in thetank and begin finding their way back to the surface of the othergloves. Dipping is only an acceptable application method if themanufacturer is willing to monitor the protein buildup in the tank andchange to a fresh tank of the liquid as necessary. But once again thismethod will cause unnecessary cost to be added to the glove. In thispreferred online method the gloves go through virtually every step ofthe manufacturing process except the final drying ovens. Just prior tothe final drying ovens a spray station is incorporated into themanufacturing line to spray the liquid onto the glove. In an onlineapplication of the coating the spray station sprays the desired amountof liquid onto the glove and the glove then proceeds to the drying ovenswhere the water carrier is evaporated from the liquid, resulting in adry coating on the surface of the glove. In the final removal of theglove from the porcelain glove mold the glove is stripped and turnedinside out which puts the dried coating on to the inside or donningsurface of the glove.

Another method which can be used is online dipping. The steps are thesame as those described in the online spray method, except the glove isdipped in a tank of liquid instead of sprayed with the liquid. The costsaving aspects of being able to manufacture larger quantities at lowerprices is somewhat maintained, but there is a problem with a build up ofallergenic latex protein which will then be transferred back to othergloves if the tank is not regularly monitored for the water solubleprotein and changed as necessary.

If this online method is not available due to a lack of technology andequipment, the gloves can be coated using an offline manufacturingmethod. Here the liquid is applied to the gloves by spraying a batch ofclean loose gloves that are arranged inside out. But bear in mind thatturning the gloves is a manual process which creates additional expense.The gloves are tumbled so that hopefully the surfaces of every glovewill have a better chance of being exposed to liquid as it is sprayed inthe tumbler. This step of tumbling of the gloves continues to occur evenafter the spraying of the liquid has already stopped. This keeps thegloves from sticking together and gives the best chance that the liquidcoating is uniformly applied. The spraying and tumbling are thenpreferably repeated for the desired number of times. After the lastapplication the liquid to the gloves, the gloves are completely dried bytumbling with heating until the gloves are dry. The number of times thisprocess must be done in an offline method needs to be sufficient, giventhe particular dryer and spray nozzle configuration, to leave at least adesired minimum amount, and/or no more than a desired maximum amount, ofcoating on substantially every glove. In this more costly and lessdesirable method the gloves need to be turned one time prior to theirbeing coated with the liquid and then once the coating has been appliedand dried they must be manually turned again.

Preferably, the spraying and drying steps can all be performed within acommercial heat tumble dryer, for example, as follows. After a waterbath at the end of the chlorination process the gloves are removed fromthe water bath and dumped into the heat tumble dryer. The dryer thenstarts tumbling the gloves. Preferably, the tumbling is accompanied byheating of the gloves with hot air and continues until the gloves aredry or mostly dry. Then, a spray nozzle configured to spray the liquidas a fine mist starts spraying the liquid onto the gloves in the dryer.During the spraying, the tumbling and heating continues as necessary.The spraying and tumbling may be repeated for several iterations. Afterthe last iteration of spraying, the gloves are dried, preferably bytumbling with heating until the gloves are dry. The number of cycles andlength of the cycle durations and the amount of liquid to use should bechosen to be sufficient, given the particular dryer and spray nozzleconfiguration, to leave at least a desired minimum thickness, and/or nomore than a desired maximum thickness, of dried coating on substantiallyevery glove.

The amount of liquid required in an offline application depends upon thesize of the batch, the method for applying the liquid and the thicknessof the desired coating. For example, for a batch of about 3000 gloves,two kilograms of rice starch liquid, COEW, BGS, or Polycoat may besprayed in about 4 or 5 spray iterations, with the spray iterationsspaced about 2 to 5 minutes apart, and with each spray iteration havinga spray duration of about 30 to 90 seconds in a tumbling dryer. Eachspray cycle is preferably followed by a tumbling cycle. The finaliteration of tumbling is of sufficient duration to dry the gloves andespecially should include heating. For example, the final iteration oftumbling may be chosen so that the total duration of tumbling andheating gloves where the liquid is applied for all the steps is about 35to 40 minutes.

The overall objective is to coat the glove with a water extract of theselected starch composition, whether single grain or multiple grain, orperhaps non-grain starch, optionally including the colloidal oatmealand/or beta glucan, for their skin protectant properties. The liquid isdried on the glove to leave a film-like coating which can have embeddedtherein smaller particles of the beneficial material where the slurrydoes not exceed the gelatinization temperature of a respective starchycomponent.

Where the starch/grain composition of the so-developed liquid does notcontain colloidal oatmeal, or contains only a small fraction ofcolloidal oatmeal, then the nomenclature may change to something likeStarch Extract Water or Grain Extract Water, or some other suchnomenclature. However, in the interest of consistency herein, unlessotherwise specifically indicated, all such compositions are hereinreferred to generically as COEW.

As appreciated by those skilled in the art, the rice starch powder, withor without colloidal oatmeal, with or without additive(s) 20, and withor without the alternative dry powdered plant materials describedpreviously herein; or in the alternative COEW, BGS or Polycoat; can beused to apply a coating to any flexible elastomeric article, notnecessarily just glove 10 shown in FIG. 1, having at least one elastomerlayer and having a wearer-contacting surface and a distal surfacedisposed distal the wearer-contacting surface, using the methodsdisclosed herein. An exemplary flexible elastomeric article to which thedry powdered rice starch, with or without the additives, or COEW and/orBGS, may be applied, includes a condom.

One skilled in the art will appreciate that many variations are possiblewithin the scope of the claims. Thus, while the disclosure isparticularly shown and described above, it will be understood by thoseskilled in the art that these and other changes in form and details maybe made therein without departing from the spirit and scope of theclaims.

1. An elastomeric article comprising: a flexible body having an innercavity, the inner cavity defining an inner surface of the body, an outersurface being defined outwardly of the body; and a substantially drycoating overlying at least one of the inner surface of the body and theouter surface of the body, said coating comprising beta glucan in a formthat provides less than a specified amount of particulate on theelastomeric article, resulting in a substantially powder-freeelastomeric article.
 2. The elastomeric article of claim 1 wherein thecoating further comprises colloidal oatmeal.
 3. The elastomeric articleof claim 1 wherein the beta glucan comprises oat beta glucan.
 4. Theelastomeric article of claim 1 wherein the elastomeric article comprisesa glove.
 5. The elastomeric article of claim 1 wherein the specifiedamount of particulate is 2 milligrams.
 6. A method for manufacturing aliquid that includes beta glucan, the method comprising the steps of:mixing a predetermined quantity of beta glucan powder with apredetermined quantity of water in a manner that minimizes likelihood ofclump formation in the resultant mixture; and mixing the mixture toproduce a beta glucan solution that has a concentration of particleshaving a size greater than a selected maximum particle size that is lessthan a predetermined threshold.
 7. An elastomeric article coated with adried form of the liquid manufactured in claim
 6. 8. The elastomericarticle in claim 7 wherein the elastomeric article comprises a glove. 9.The method of claim 6 wherein the beta glucan comprises oat beta glucan.10. The method of claim 6 wherein the concentration of the beta glucanin the beta glucan solution is from 1% to 50% by weight.
 11. The methodof claim 6 further comprising the steps of: mixing powdered colloidaloatmeal with water at a temperature less than 50 degrees C. to form aslurry; holding the slurry at a temperature of 30 to 50 degrees C. forat least 15 minutes; cooling the slurry; while maintaining the slurry inthe cooled condition, removing remaining particulate material above aselected maximum particle size, thereby producing a liquid having aconcentration of particles having a size greater than the selectedmaximum particle size that is less than a predetermined threshold; andmixing the liquid with the beta glucan solution.
 12. The method of claim11 wherein the step of removing remaining particulate material above theselected maximum particle size is performed using a centrifuge.
 13. Themethod of claim 11 wherein the step of removing remaining particulatematerial above the selected maximum particle size is performed byallowing the cooled slurry to sit for a predetermined time to allowparticles to settle to the bottom, and removing the liquid from the topof the slurry.
 14. The method of claim 11 wherein the step of removingremaining particulate material above the selected maximum particle sizeis performed using a filter.
 15. A method for manufacturing anelastomeric article having a flexible body having an inner cavity, theinner cavity defining an inner surface of the body, an outer surfacebeing defined outwardly of the body, the method comprising the steps of:(A) forming the elastomeric article; (B) applying a liquid comprisingbeta glucan to the elastomeric article, the liquid having aconcentration of particles having a size greater than a selected maximumparticle size that is less than a predetermined threshold; and (C)drying the liquid to form a substantially dry coating on the elastomericarticle that provides less than a specified amount of particulate on theelastomeric article, resulting in a substantially powder-freeelastomeric article.
 16. The method of claim 15 wherein the liquidfurther comprises colloidal oatmeal.
 17. The method of claim 15 whereinthe beta glucan comprises oat beta glucan.
 18. The method of claim 15wherein the elastomeric article comprises a glove.
 19. The method ofclaim 15 wherein the specified amount of particulate is 2 milligrams.20. The method of claim 15 wherein the selected maximum particle size is2 microns.
 21. The method of claim 15 wherein steps (A), (B) and (C) areall preformed as part of an online manufacturing process.